Job Information
Amgen Process Development Principal Scientist - Thousand Oaks CA in Thousand Oaks, California
468114BR
Auto req ID:
468114BR
Company:
Amgen
Job Code:
Pharmaceutical Pharmaceutical
Job Description:
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Process Development Principal Scientist
What you will do
Let’s do this! Let’s change the world!
Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to)
synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), and live oncolytic viruses. Located at our Thousand Oaks, CA office the PD Principal Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead and group lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.
Key responsibilities:
Supervise and provide technical support for a team that provides analytical support for late stage product development
Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, being responsible for all analytical work to support the program
Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
Manage activities at contract manufacturing and testing sites
Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
Provide expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development
Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
Position Title:
Process Development Principal Scientist - Thousand Oaks CA
Job Category:
Scientific Research & Development
Minimum Education Required:
Bachelors
City*:
Thousand Oaks
Additional Qualifications/Responsibilities:
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of Analytical Chemistry, Biochemistry or equivalent experience OR
Master’s degree and 5 years of Analytical Chemistry, Biochemistry or equivalent experience OR
Bachelor’s degree and 7 years of Analytical Chemistry, Biochemistry or equivalent experience
Preferred Qualifications:
Doctorate degree with 7-10+ years in Analytical Chemistry, Biochemistry or equivalent.
Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.
Successful track record of managing and developing team of scientist.
Strong background in bioanalytical research and development focusing on method development to study proteins and peptides using novel separation techniques.
Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF
Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.
Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as glycosylation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
Strong problem solving and effective multi-functional interpersonal skills.
Ability to develop, validate, transfer and remediate methods for in-process, release and stability testing
Experience in analytical testing requirements for immediate release and controlled release solid dosage forms, liquid formulation or lyophilized formulation
Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner
Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, managing deliverables against timelines
Strong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
Works well in cross-functional teams, and across various geographic locations in different time zones
Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
Experience with protein-based and live modality therapies is beneficial (monoclonal antibodies, bi/tri-specific antibodies, fusion proteins, gene therapy, etc.)
A self-starter and team player with strong leadership and decision-making skills, who can provide mentorship to junior staff
Ability to multitask, effectively plan and follow through on complex projects
Someone who strongly values working on and leading teams
Salary Range
155,244.00 USD - 183,930.00 USD
State*:
California
Salary Range:
$100,000